Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,

Transcription

1 Official Journal of the European Communities No L 237/3 EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs THE EUROPEAN PARLIAMENT AND THE COUNCIL OE THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof, Whereas the use of sweeteners to replace is justified for the production of energy-reduced food, noncariogenic foodstuffs or food without added s, for the extension of shelf life through the replacement of, and for the production of dietetic products, Having regard to Council Directive 89/ 107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption ('), and in particular Article 3 ( 2 ) thereof, Having regard to the proposal from the Commission ( 2 ), Having regard to the opinion of the Economic and Social Committee ( 3 ), After consultation of the Scientific Committee for Food, Acting in accordance with the procedure referred to in Article 189b of the Treaty ( 4 ), Whereas differences between national laws relating to sweeteners and their conditions of use hinder the free movement of foodstuffs ; whereas this situation may create conditions of unfair competition ; Whereas the prime consideration for any rules on sweeteners and their conditions of use should be the need to protect and inform the consumer ; Whereas, having regard to the most recent scientific and toxicological information, these substances are to be permitted only for certain foodstuffs and under certain conditions of use ; Whereas this Directive does not affect rules relating to functions other than the sweetening properties of the substances covered by this Directive ; ( ) OJ No L 40, , p. 27. Directive as amended by Directive 94/34/EC ( see page 1 of this Official Journal ). ( 2 ) OJ No C 206, , p. 3. ( 3 ) OJ No C 332, , p. 10. ( ) Opinion of the European Parliament of 29 October 1993 ( OJ No C 305, ), confirmed on 2 December 1993 ( OJ No C 342, ), Council common position of 11 November 1993 ( not yet published in the Official Journal ) and Decision of the European Parliament of 9 March 1994 ( OJ No C 91, , p. 81 ). HAVE ADOPTED THIS DIRECTIVE : Article Z 1. This Directive is a specific directive forming a part of the comprehensive directive within the meaning of Article 3 of Directive 89/ 107/EEC. 2. This Directive shall apply to food additives, hereinafter referred to as 'sweeteners', which are used : to impart a sweet taste to foodstuffs, as table-top sweeteners. 3. For the purposes of this Directive, 'with no added ' and 'energy-reduced' in column III of the Annex shall be defined as follows : 'with no added ': without any added mono- or disaccharides or any other foodstuff used for its sweetening properties, 'energy-reduced': with an energy value reduced by at least 30% compared with the original foodstuff or a similar product. 4. This Directive shall not apply to foodstuffs with sweetening properties. Article 2 1. Only sweeteners listed in the Annex may be placed on the market with a view to : sale to the ultimate consumer, or use in the manufacture of foodstuffs. 2. Sweeteners referred to in the second indent of paragraph 1 may only be used in the manufacture of the foodstuffs listed in the Annex under the conditions specified therein.

2 No L 237/4 Official Journal of the European Communities Except where specially provided for, sweeteners may not be used in foods for infants or young children, as specified in Directive 89/398/EEC ( 1 ). 4. The maximum s indicated in the Annex refer to ready-to-eat foodstuffs prepared according to the instructions for use. Article 7 1. Where the procedure laid down in this Article is to be followed, the matter shall be referred to the Standing Committee for Foodstuffs ( hereinafter referred to as 'the Committee') by the chairman on his own initiative or at the request of the representative of a Member State. Article 3 1. This Directive shall apply without prejudice to specific directives permitting additives listed in the Annex to be used for purposes other than sweetening. 2. This Directive shall also apply without prejudice to Community provisions governing the composition and the description of foodstuffs. Article 4 Where there are differences of opinion as to whether sweeteners can be used in a given foodstuff under the terms of this Directive, it may be decided by the procedure laid down in Article 7 whether that foodstuff is to be considered as belonging to one of the categories listed in column III of the Annex. Artikel 5 1. The sales description of a table-top sweetener must include the term.. -based table-top sweetener', using the name(s ) of the sweetening substance(s ) used in its composition. 2. The labelling of a table-top sweetener containing polyols and/or aspartame must bear the following warnings : polyols : 'excessive consumption may induce laxative effects', aspartame : 'contains a source of phenylalanine'. Provisions concerning : Article 6 the details which must appear on the labelling of foodstuffs containing sweeteners in order to make their presence clear, warnings concerning the presence of certain sweeteners in foodstuffs, shall be adopted in accordance with the procedure laid down in Article 7 before expiry of the time limit laid down in the first indent of Article 9 ( 1 ). 0 ) OJ No L 186, , p The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2 ) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote. 3. ( a ) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee. ( b ) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission. Article 8 1. Within three years of adoption of this Directive, in accordance with the general criteria of point 4 of Annex II to Directive 89/ 107/EEC, Member States shall establish a system of consumer surveys to monitor sweetener consumption. The details of this monitoring system shall be coordinated in accordance with the procedure laid down in Article Within five years of adoption of this Directive, the Commission shall submit to the European Parliament and the Council a report, based on information obtained through the monitoring system referred to in paragraph 1, on changes in the sweeteners market, levels of use, and whether there is a further need to restrict conditions of use, including by means of appropriate warnings to consumers, to ensure that use does not exceed the acceptable daily intake. If necessary, the report shall be accompanied by proposals for amendment to this Directive.

3 Official Journal of the European Communities No L 237/5 Article 9 official publication. The methods of making such reference shall be laid down by the Member States. 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December These measures are intended to : allow, not later than 31 December 1995, trade in and use of products conforming to this Directive, prohibit, not later than 30 June 1996, trade in and use of products not conforming to this Directive ; products put on the market or labelled before that date which do not comply with this Directive may, however, be marketed until stocks are exhausted. They shall inform the Commission forthwith thereof. Article 10 This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities. Article 11 This Directive is addressed to the Member States. Done at Brussels, 30 June When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their For the European Parliament The President E. KLEPSCH For the Council The President A. BALTAS

4 No L Official Journal of the European Communities ANNEX E420 Sorbitol Desserts and similar products quantum satis ( i ) Sorbitol ( ii ) Sorbitol syrup Water-based flavoured desserts, E421 Mannitol added energy-reduced or with no E 953 Isomalt Milk - and milk-derivative-based preparations, energy-reduced E 965 Maltitol or with no added ( i ) Maltitol Fruit- and vegetable-based desserts, energy-reduced or with ( ii ) Maltitol syrup no added E 966 Lactitol Egg-based desserts, energy-reduced or with no added E 967 Xylitol Cereal-based desserts, energy-reduced or with no added Breakfast cereals or cereal-based products, energy reduced or with no added Fat-based desserts, energy-reduced or with no added Edible ices, energy-reduced or with no added Jams, jellies, marmalades and crystallized fruit, energyreduced or with no added Fruit preparations, energy-reduced or with no added, with the exception of those intended for the manufacture of fruit-juice-based drinks with no added Dried-fruit-based confectionery, energy-reduced or with no added Starch-based confectionery, energy-reduced or with no added Cocoa-based products, energy-reduced or with no added Cocoa-, milk-, dried-fruit - or fat-based sandwich spreads, energy-reduced or with no added Chewing gum with no added Sauces Mustard Fine bakery products, energy-reduced or with no added Products intended for particular nutritional uses Solid food supplements/dietary integrators E 950 Acesulfame K Non-alcoholic drinks Water-based flavoured drinks, energy-reduced or with no added Milk - and mijk-derivative-based or fruit-juice-based drinks, enertiy-reduced or with no added 350 mg/1 350 mg/1

5 Official Journal of the European Communities No L 237/7 E 950 (cont'd) Desserts and similar products Water-based flavoured desserts, energy-reduced or with no added Milk - and milk-derivative-based preparations, energy-reduced or with no added Fruit- and vegetable-based desserts, energy-reduced or with no added Egg-based desserts, energy-reduced or with no added Cereal-based desserts, energy-reduced or with no added Fat-based desserts, energy-reduced or with no added ' snacks': certain flavours of ready to eat, prepacked, dry, savoury starch products and coated nuts with no added Cocoa - or dried-fruit-based confectionery, energy-reduced or with no added Starch-based confectionery, energy-reduced or with no added mg/kg Cocoa -, milk -, dried-fruit- or fat-based sandwich spreads, energy-reduced or with no added mg/kg Chewing gum with no added mg/kg Cider and perry 350 mg/ 1 Alcohol-free beer or with an alcohol content not exceeding 1,2% vol 350 mg/1 ' Biere de table/tafelbier/table beer' (original wort content less than 6% ) except for ' Obergariges Einfachbier' 350 mg/1 Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH 350 mg/1 Brown beers of the ' oud bruin ' type 350 mg/1 Edible ices, energy-reduced or with no added 800 mg/kg Canned or bottled fruit, energy-reduced or with no added Energy-reduced jams, jellies and marmalades mg/kg Energy-reduced fruit and vegetable preparations Sweet-sour preserves of fruit and vegetables 200 mg/kg Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and molluscs 200 mg/kg Sauces Mustard Fine bakery products for special nutritional uses mg/kg Complete formulae for weight control intended to replace total dailv food intake or an individual meal 450 msi/ke

6 No L 237/8 Official Journal of the European Communities E 950 Complete formulae and nutritional supplements for use (cont'd.) under medical supervision 4 Liquid food supplements/dietary integrators 350 mg/1 Solid food supplements/dietary integrators Vitamins and dietary preparations mg/kg E951 Aspartame Non-alcoholic drinks Water-based flavoured drinks, energy-reduced or with no added Milk - and milk-derivative-based or fruit-juice-based drinks, energy-reduced or with no added 600 mg/1 600 mg/1 Desserts and similar products Water-based flavoured desserts, energy-reduced or with no added mg/kg Milk - and milk-derivate-based preparations, energy-reduced or with no added mg/kg Fruit- and vegetable-based desserts, energy-reduced or with no added mg/kg Egg-based desserts, energy-reduced or with no added mg/kg Cereal-based desserts, energy-reduced or with no added mg/kg Fat-based desserts, energy-reduced or with no added mg/kg 'snacks': certain flavours of ready to eat, prepacked, dry, savoury starch products and coated nuts with no added mg/kg Cocoa - or dried-fruit-based confectionery, energy-reduced or with no added Starch-based confectionery, energy-reduced or with no added mg/kg mg/kg Cocoa-, milk-, dried-fruit- or fat-based sandwich spreads, energy-reduced or with no added mg/kg Chewing gum with no added 5 Cider and perry 600 mg/1 Alcohol-free or with an alcohol content not exceeding 1,2 % vol 600 mg/1 'Biere de table/tafelbier/table beer' ( original wort content less than 6% ) except for ' Obergariges Einfachbier' 600 mg/1 Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH 600 mg/1 Brown beers of the 'oud bruin ' type 600 mg/1

7 Official Journal of the European Communities No L 237/9 E 951 (cont 'd) Edible ices, energy-reduced or with no added 800 mg/kg Canned or bottled fruit, energy-reduced or with no added mg/kg Energy-reduced jams, jellies and marmalades mg/kg Energy-reduced fruit and vegetable preparations mg/kg Sweet-sour preserves of fruit and vegetables 300 mg/kg Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and molluscs 300 mg/kg Sauces Mustard Fine bakery products for special nutritional uses mg/kg Complete formulae for weight control intended to replace total daily food intake or an individual meal 800 mg/kg Complete formulae and nutritional supplements for use under medical supervision mg/kg Liquid food supplements/dietary integrators 600 mg/kg Solid food supplements/dietary integrators mg/kg Vitamins and dietary preparations 5 E 952 Cyclamic acid andits Na Non-alcoholic drinks and Ca salts Water-based flavoured drinks, energy-reduced or with no added Milk - and milk-derivative-based or fruit-juice-based drinks, energy-reduced or with no added 400 mg/1 400 mg/1 Desserts and similar products - Water-based flavoured desserts, energy-reduced or with no added Milk- and milk-derivative-based preparations, energy-reduced or with no added Fruit- and vegetable-based desserts, energy-reduced or with no added Egg-based desserts, energy-reduced or with no added 2 Cereal-based desserts, energy-reduced or with no added 2 Fat-based desserts, energy-reduced or with no added 2 with no added Cocoa- or dried-fruit-based confectionery, energy-reduced or with no added Starch-based confectionery, energy-reduced or with no added Cocoa-, milk-, dried-fruit- or fat-based sandwich spreads, energy-reduced or with no added

8 No L 237/10 Official Journal of the European Communities E 952 Chewing gum with no added 1 (cont d) Edible ices, energy-reduced or with no added 2 Canned or bottled fruit, energy-reduced or with no added mg/kg Energy-reduced jams, jellies and marmalades mg/kg Energy-reduced fruit and vegetable preparations 2 Fine bakery products for special nutritional uses mg/kg Complete formulae for weight control intended to replace total daily food intake or an individual meal Complete formulae and nutritional supplements for use under medical supervision 400 mg/kg 400 mg/kg Liquid food supplements/dietary integrators 400 mg/kg Solid food supplements/dietary integrators E 954 Saccharin and its Na, K Non-alcoholic drinks and Ca salts Water-based flavoured drinks, energy-reduced or with no added 80 mg/1 Milk - and milk-derivative-based or fruit-juice-based drinks, energy-reduced or with no added 80 mg/ 1 ' Gaseosa': non-alcoholic water-based drink with added carbon dioxide, sweeteners and flavourings 100 mg/1 Desserts and similiar products Water-based flavoured desserts, energy-reduced or with no added Milk - and milk-derivative-based preparations, energy-reduced or with no added Fruit- and vegetable-based desserts, energy-reduced or with no added Egg-based desserts, energy-reduced or with no added Cereal - based desserts, energy-reduced or with no added Fat-based desserts, energy-reduced or with no added 'snacks': certain flavours of ready to eat, prepacked, dry savoury starch products and coated nuts with no added Cocoa - or dried-fruit-based confectionery, energy-reduced or with no added Starch-based confectionery, energy-reduccd or with no added 300 mg/kg Essoblaten 800 mg/kg Cocoa -, milk-, dried-fruit- or fat-based sandwich spreads, energy-reduced or with no added 200 mg/kg

9 Official Journal of the European Communities No L 237/11 E 954 Chewing gum with no added mg/kg (cont d) Cider and perry 80 mg/1 Alcohol-frec beer or with an alcohol content not exceeding 1,2% vol 80 mg/1 'Biere de table/tafelbier/table beer' ( original wort content less than 6% ) except ' Obergariges Einfachbier ' 80 mg/1 Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH 80 mg/1 Brown beers of the 'oud bruin ' type 80 mg/ 1 Edible ices, energy-reduced or with no added Canned or bottled fruit, energy-reduced or with no added 200 mg/kg Energy-reduced jams, jellies and marmalades 200 mg/kg Energy-reduced fruit and vegetable preparations 200 mg/kg Sweet-sour preserves of fruit and vegetables 160 mg/kg Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and molluscs 160 mg/kg Sauces 160 mg/kg Mustard 320 mg/kg Fine bakery products for special nutritional uses 170 mg/kg Complete formulae for weight control intended to replace total daily food intake or an individual meal Complete formulae and nutritional supplements for use under medical supervision 240 mg/kg 200 mg/kg Liquid food supplements/dietary integrators 80 mg/kg Solid food supplements/dietary integrators Vitamins and dietary preparations mg/kg E 957 Thaumatin with no added Cocoa - or dried-fruit-based confectionery, energy-reduced or with no added Chewing gum with no added Vitamins and dietary preparations 400 mg/kg E 959 Neohesperidine DC Non-alcoholic drinks Water-based flavoured drinks, energy-reduced or with no added Milk- and milk-derivative-based drinks, energy-reduced or with no added 30 mg/l 50 mg/1 Fruit-juice-based drinks, energy-reduced or with no added 30 mg/ 1

10 No L 237/12 Official Journal of the European Communities E 959 (cont 'd) Desserts and similar products Water-based flavoured desserts, energy-reduced or with no added Milk - and milk-derivative-based preparations, energy-reduced or with no added Fruit- and vegetable-based desserts, energy-reduced or with no added Egg-based desserts, energy-reduced or with no added Cereal-based desserts, energy-reduced or with no added Fat-based desserts, energy-reduced or with no added with no added Cocoa - or dried-fruit-based confectionery, energy-reduced or with no added Starch-based confectionery, energy-reduced or with no added Cocoa -, milk-, dried-fruit- or fat-based sandwich spreads, energy-reduced or with no added 1 Chewing gum with no added 400 mg/kg Cider and perry 20 mg/1 Alcohol-free beer or with an alcohol content not exceeding 1,2 % vol 1 0 mg/ 1 ' Biere de table/tafelbier/table beer ' ( original wort content less than 6% ) except ' Obergariges Einfachbier' 10 mg/1 Beers with a minimum acidity of 30 milli-equivalents expressed as NaOH 10 mg/1 Brown beers of the ' oud bruin' type 10 mg/1 Edible ices, energy-reduced or with no added Canned or bottled fruit, energy-reduced or with no added Energy-reduced jams, jellies and marmalades Sweet-sour preserves of fruit and vegetables 1 00 mg/kg Energy-reduced fruit and vegetable preparations Sweet-sour preserves and semi-preserves of fish and marinades of fish, crustaceans and molluscs 30 mg/kg Sauces Mustard Fine bakery products for special nutritional uses 1 Complete formulae for weight control intended to replace total daily food intake or an individual meal Liquid food supplements/dietary integrators Solid food supplements/dietary integrators